BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEART SYSTEM

    MDR report key: 2203745 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01340
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    February 28, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DPS
    PMA / PMN Number
    K024278
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. CORRECTION NOTE: THIS COMPLAINT WAS INADVERTENTLY SUBMITTED UNDER THE MEDICAL DEVICE REPORTING REGULATIONS, AS THE POTENTIAL FOR INJURY IS NOT LIKELY FOR THIS TYPE OF EVENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT SINCE AN UPDATE OCCURRED, DISCREPANCIES HAVE BEEN NOTED IN THE CONGENITAL HEART DISEASE DIAGNOSIS ON VARIOUS PACEART TRANSMISSIONS. IT WAS FURTHER REPORTED THAT PHYSICIANS HAVE BEEN DISPLAYED AS REFERRING PHYSICIANS WHEN THEY ARE NOT THE REFERRING PHYSICIAN. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT SINCE AN UPDATE OCCURRED, DISCREPANCIES HAVE BEEN NOTED IN THE CONGENITAL HEART DISEASE DIAGNOSIS ON VARIOUS PACEART TRANSMISSIONS. IT WAS FURTHER REPORTED THAT PHYSICIANS HAVE BEEN DISPLAYED AS REFERRING PHYSICIANS WHEN THEY ARE NOT THE REFERRING PHYSICIAN. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEART SYSTEM SOFTWARE DPS MEDTRONIC, INC. GCIII ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other